cGMP Associate Director, Process Development

About the role

The University of Southern California (USC), founded in 1880, is located in the heart of downtown L.A. and is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the “Trojan Family,” which is comprised of the faculty, students and staff that make the university what it is.

Responsibilities

• Develops and implements strategies that proactively identify and mitigate risks. Establishes strategic goals and objectives for product manufacturing operations. Enhances and supports cross-functional interactions and activity prioritization. Regularly ensures compliance with all relevant regulatory requirements.
• Oversees the implementation of project plans (e.g., process and assay development and qualification), support tech transfer of processes to cGMP manufacturing and assays to QC. Develops and reviews SOPs, protocols and technical reports.
• Works closely with internal/external stakeholders to ensure project success and competition. Coaches and develops staff and coordinates departmental hiring/staffing plans. Identifies improvement opportunities to optimize workflows and eliminate inefficiencies. Establishes metrics and reports on the state of cGMP operations to senior management.
• Participates in vendor management and qualification visits as needed. Attends regular meetings with management discussing progress reports, facility needs and other required items.
• Ensures timely delivery of project goals and creates periodic progress reports summarizing status and potential risks. Assists with design and delivery of training courses. Stays current with new/emerging technologies and approaches, leveraging the latest industry knowledge to facilitate opportunities for innovation and continuous improvement.
• Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold principles of the USC Code of Ethics. Creates staff development opportunities, reads and contributes to journals, and participates in professional organizations, meetings, conferences, seminars, and training courses.
• Lead process development and optimization efforts of cell therapy products, including the design and production of viral vectors. Support assay development and qualification for product testing.
• Lead technology transfer to cGMP manufacturing and quality control, ensuring efficient scaling and implementation. Develop and review SOPs, protocols and process development reports. Authoring CMC documentation.
• Oversee lab setup and work with cGMP facility management to allocate resources and infrastructure for efficient project execution.

Requirements

• Master’s degree in a scientific discipline (e.g., pharmaceutical, biologics).
• Four years of cellular or biological manufacturing experience (e.g., process development and analytical methods).
• Proven experience in leadership/management roles.
• Demonstrated experience in academic administration and quality management.
• Solid knowledge base in Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs), cellular and gene therapies, translational research, and the business of science.
• Demonstrated ability to work as an individual contributor and in dynamic team environments.
• Excellent written and oral communication skills.

Qualifications

• Doctorate in biotechnology or other related life science disciplines.
• Experience and knowledge of standard operating procedures in cGMP laboratory settings.
• Ability to drive vendor selection and engagement, manage relationships, evaluate vendor data, document test plans, and develop deployment workbooks.

Skills

• Master’s degree in a scientific discipline (e.g., pharmaceutical, biologics).
• Proven experience in leadership/management roles.
• Demonstrated experience in academic administration and quality management.
• Solid knowledge base in Good Manufacturing Practices (e.g., cGMPs, GLPs, GDPs), cellular and gene therapies, translational research, and the business of science.
• Demonstrated ability to work as an individual contributor and in dynamic team environments.
• Excellent written and oral communication skills.
• Doctorate in biotechnology or other related life science disciplines.
• Experience and knowledge of standard operating procedures in cGMP laboratory settings.
• Ability to drive vendor selection and engagement, manage relationships, evaluate vendor data, document test plans, and develop deployment workbooks.

Benefits

This is a 3 year fixed-term position.

Pay

The annual base salary range for this position is $130,000 - $140,000. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidates's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

Schedule

N/A